MAUDE Adverse Event Report: ANGIODYNAMICS, INC H787CT80LPBDVI0; SMARTPORT+ LOW PROFILE PORT WITH ENDEXO AND VORTEX TECHNOLOGY

Catalog Number H787CT80LPBDVI0

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

An end user reported an issue with a 8f low profile plastic vortex port detached bioflo catheter filled sh valved introducer.A few weeks following port placement, the patient arrived for a chemotherapy infusion; however, nurses were unable to establish blood return.The patient was unable to receive treatment and has been scheduled for a removal and replacement procedure.The patient did not experience any adverse effects or harm as a result of this incident.

Manufacturer Narrative

The reported device has not been returned to the manufacturer for evaluation.An investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Manufacturer Narrative

The customer's reported complaint description of port did not provide blood return after 6 weeks in situ cannot be confirmed, since no port/catheter sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the directions for use (dfu) item number 14600330-01 that is provided in the reported kit contains the following directions and precautions: contraindications · catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.Warnings: · do not suture catheter to port, port stem, or surrounding tissue.Any damage or constriction of catheter may compromise power injection performance and catheter integrity.· do not forcefully flush the port system with any syringe size.After confirmation of patency by detecting no resistance and the presence of a blood return, use syringes appropriately sized for the medication being injected.Do not transfer the medication to a larger syringe.· failure to ensure patency of the catheter prior to power injection studies may result in port system failure and patient injury may occur.· do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure and patient injury may occur.Absence of a blood return or a poor blood return can be a sign of a potential complication such as occlusion, kinking, breakage, pinch-off syndrome, fibrin formation, thrombosis or malposition.This should be evaluated prior to device usage.· a blood return should be present prior to usage of device for any therapy or testing.· if the patient complains of pain, or there is swelling when the device is flushed or when medication or contrast media is administered, evaluate the device for infiltration, proper needle placement, and potential complications such as occlusion, kinking, breakage, pinch-off syndrome, thrombosis or malposition.Failure to assess these complaints or observations can lead to device failure.Precautions to avert device damage and/or patient injury during catheter placement: · carefully follow the catheter to port connection technique provided in the dfu to ensure proper device connection and to avoid catheter damage.· assure tight connection between port body and catheter.· after implantation or any treatment via the port, the system should be flushed with normal saline for injection per institutional protocol.Potential complications use of an angiodynamics port system involves potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: catheter occlusion, malposition, dislodgement, fragmentation, migration, disconnection or rupture.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: H787CT80LPBDVI0
• Type of Device: SMARTPORT+ LOW PROFILE PORT WITH ENDEXO AND VORTEX TECHNOLOGY
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 18827628
• MDR Text Key: 336858037
• Report Number: 1317056-2024-00042
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT80LPBDVI0
• UDI-Public: H787CT80LPBDVI0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: H787CT80LPBDVI0
• Device Lot Number: 5796677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1